All insights: DiGA development & approval in 2026
Since the DiGA concept was launched, we have learned a great deal about the development of digital health applications. We share as much of this knowledge as possible with (prospective) DiGA manufacturers through our specialist articles. This means that not everyone...
Switzerland: Reimbursement for digital health applications (DiGA & dGA)
In 2020, Germany became the first country to establish DiGA in regular healthcare. This means that digital health applications can be approved in a structured, transparent process. Once approved, DiGA can then be prescribed by doctors in a similar way to medication....
Is your app a DiGA? Definition criteria of digital health applications
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical software...
BSI TR-03161 for DiGA: Data Security Certification
Since January 1, 2025, manufacturers of digital health applications (DiGA) must prove compliance with data security requirements by means of an official certificate. The basis for certification is BSI TR-03161, which was first published in 2020. The BfArM checks...
DiGA Guide: History of all changes
The BfArM updates the DiGA guidelines regularly. Unfortunately, there is no detailed change history available for this yet. We therefore continuously review all changes to the DiGA guidelines and prepare them for you. We present all changes here with comments in a...
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